VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma
- Conditions
- B-Cell LymphomaFollicular LymphomaMarginal Lymphoma
- Registration Number
- NCT00085696
- Lead Sponsor
- Millennium Pharmaceuticals, Inc.
- Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of VELCADE when given in combination with rituximab in patients with Relapsed or Refractory Indolent B-Cell Lymphoma. This study will investigate if treatment with VELCADE and rituximab increases the time it takes your lymphoma to get worse.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
-
Male or female subject 18 years or older
-
Diagnosis of B-cell lymphoma (CD20+) of
- follicular lymphoma (grades 1, 2, and 3) or
- marginal zone lymphoma (extranodal, nodal, and splenic)
-
Documented relapse or progression following prior anti-neoplastic treatment.
-
At least 1 measurable lymph node mass that is >1.5 cm.
-
No active CNS lymphoma
-
Voluntary consent
- Previous treatment with VELCADE
- Any anti-neoplastic or experimental therapy within 3 weeks before the first dose of study drug.
- Any treatment with nitrosoureas within 6 weeks before the first dose of study drug.
- Treatment with Zevalin™ or Bexxar® within 10 weeks before the first dose of study drug.
- Rituximab, Campath® or other unconjugated therapeutic antibody within 4 weeks before the first dose of study drug.
- Radiation therapy within 3 weeks before the first dose of study drug.
- Major surgery within 2 weeks before the first dose of study drug.
- Peripheral neuropathy or neuropathic pain
- History of allergic reaction attributable to compounds containing boron or mannitol
- Known anaphylaxis or hypersensitivity to any component of rituximab
- Diagnosed or treated for a selected malignancies other than NHL within 5 years.
- Active systemic infection requiring treatment
- Female subjects must not be pregnant, breast-feeding, or become pregnant during the course of the study.
- Male subjects who do not agree to use an acceptable method of contraception for the duration of the study
- Any serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Concurrent treatment with another investigational agent. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
Emory University Cancer Institute, Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Georgia Cancer Specialists
🇺🇸Marietta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Midwest Cancer Research Group
🇺🇸Skokie, Illinois, United States
Oncology/Henmatology Associates of Kansas City
🇺🇸Kansas City, Missouri, United States
Mid Ohio Oncology/Hematology Inc.
🇺🇸Columbus, Ohio, United States
Charleston Cancer Center
🇺🇸Charleston, South Carolina, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Utah, Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
FNVHO - US Oncology
🇺🇸Fairfax, Virginia, United States